MDR/IVDR Notified Bodies Coverage Statistics
On January 1st, 2023, the MDR/IVDR notified bodies released important statistics concerning the designation codes. It was noted that 80% of the MDR codes are covered by only 50% of the notified bodies, with five specific codes being covered by less than one-third of them. These codes are:
- MDA 0102: Active implantable devices delivering drugs or other substances
- MDA 0104: Active implantable devices utilizing radiation and other active implantable devices
- MDA 0103: Active implantable devices supporting or replacing organ functions
- MDA 0101: Active implantable devices for stimulation/inhibition/monitoring
- MDS 1002: Devices manufactured utilizing tissues or cells of human origin, or their derivatives
In relation to the IVDR, 80% of its codes are covered by 7 out of 8 notified bodies. Notably, only one IVDR code, IVD 4010 (In vitro diagnostic devices which require knowledge regarding mycology), is covered by just 5 notified bodies.